mHealth Cardiac Rehabilitation for INOCA
This study is testing a mobile health cardiac rehabilitation (mHealth-CR) program for people with Ischemia with Non-Obstructive Coronary Arteries (INOCA), a condition where you have symptoms of heart ischemia (reduced blood flow to the heart) but no major blockages in your heart arteries. The mHealth-CR program includes a personalized exercise plan with weekly phone calls from an exercise therapist, a mobile app to track your exercise and view educational materials, and a Fitbit Charge 5 to monitor your activity. Researchers want to see if this program improves your health over 3 and 12 months, specifically looking at changes in your angina (chest pain) symptoms. You can join if you are 18 or older and have been diagnosed with INOCA. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase 2 randomized study involving 250 participants. You would be randomly assigned to either receive the mHealth-CR program or usual care.
- What's involved
- The study intervention lasts for 3 months, during which you would communicate weekly with an exercise therapist and use the mHealth-CR software and Fitbit device.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your angina symptoms will be checked at 3 months and 12 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
mHealth-CArdiac REhabilitation for INOCA
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Harmony Reynolds, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Change in Seattle Angina Questionnaire (SAQ) scoreBaseline, Month 3
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
- Change in Seattle Angina Questionnaire (SAQ) scoreBaseline, Month 12
The SAQ measures disease-related health status (functional status and quality of life) and has a four-week recall period. The SAQ generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
- Weekly percent completion of the mHealth-CR programMonth 3
Weekly engagement will be measured as the fraction of the following elements completed each week: exercise therapy-directed activities, daily entry of exercise data and rated perceived exertion (RPE); completed weekly phone call with exercise therapist; at least one communication with exercise therapist (outside weekly phone call); reviewing educational video/text (which will vary by week). Competition will be assessed as a pseudo-continuous outcome, as the score can range from 0% (0 activities completed) to 100% (all activities completed) incorporating values for each activity.